510(k) K954736— ACCESS (POWERCLAVE)

Substantially Equivalent

Mdt Biologic Co.

Clearance details

Applicant: Mdt Biologic Co.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1995-10-16
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.